Moxidectin for LF, Cote d'Ivoire (DOLF)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04410406
• Date of registration: 27/05/2020
• Prospective Registration: Yes
• Primary sponsor: Washington University School of Medicine
• Public title: Moxidectin for LF, Cote d'Ivoire (DOLF)
• Scientific title: A Clinical Trial to Assess the Safety and Efficacy of Moxidectin Combination Treatments vs. Ivermectin Combination Treatments for Bancroftian Filariasis
• Date of first enrolment: August 20, 2020
• Target sample size: 250
• Recruitment status: Enrolling by invitation
• URL: https://clinicaltrials.gov/show/NCT04410406
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Côte D'Ivoire

Contacts

• Name: Catherine Bjerum, MD, MPH
• Affiliation: Case Western Reserve University

• Name: Benjamin Koudou, PhD
• Affiliation: Regional Hospital of Agboville, Southern Cote d'Ivoire

• Name: Toki Pascal Gabo, MD
• Affiliation: Regional Hospital of Agboville, Southern Cote d'Ivoire

• Name: Philip Budge, MD, PhD
• Affiliation: Washington University School of Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

- Provision of signed and dated informed consent form

- Male or female, aged 18-70 years

- In good general health as evidenced by medical history

- Peripheral night blood W. bancrofti Mf levels =40 Mf/mL

- No history of taking antifilarial medications in past 12 months

- Resident of the study area with no plans to change residence in the next 36 months

- For women of childbearing potential, willing to use appropriate method of
contraception for one month following each treatment

Exclusion Criteria:

- Pregnancy or currently breastfeeding

- Known allergic reactions to any of the study medications

- Evidence of severe or systemic comorbidities (aside from features of filarial
disease), as judged by the principal investigator

- Baseline biochemical abnormalities, as indicated by AST, ALT, or creatinine > 2 times
the upper limit of normal

- Evidence of urinary tract infection as indicated by 3+ nitrites on dipstick
(individuals with 1+ or 2+ nitrites will not be excluded) or underlying chronic kidney
disease as indicated by 3+ protein or 3+ blood on urine dipstick exam

- Hgb < 7 gm/dL (any such individuals will be referred to the local health center for
evaluation and treatment)

- Positive skin snip for onchocerciasis



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lymphatic Filariasis

Intervention(s)

Drug: Albendazole

Drug: Diethylcarbamazine

Drug: Ivermectin

Drug: Moxidectin

Primary Outcome(s)

Clearance of microfilaremia (IA vs. MoxA) [Time Frame: 12 months]

Clearance of microfilaremia (IDA vs. MoxDA) [Time Frame: 24 months]

Secondary Outcome(s)

Clearance of microfilaremia [Time Frame: 6, 12, 24, & 36 months]

Frequency and severity of AEs [Time Frame: From baseline treatment to 7 days post-treatment]

Inactivation of adult worm nests [Time Frame: 6, 12, & 24 months]

Plasma levels of drugs/metabolites post treatment [Time Frame: Baseline, 2, 3, 4, 6, 12, 24, & 48 hours post-treatment]

Reduction in circulating filarial antigen (CFA) counts [Time Frame: Baseline, 6, 12, & 24 months]

Reduction in Mf counts [Time Frame: Baseline, 6, 12, & 24 months]

Secondary ID(s)

202005076

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Case Western Reserve University

Regional Hospital of Agboville, Southern Cote d'Ivoire